NA 02.205.085Recalls & reported problems
Synthes GmbH · 5.0MM CANNULATED LOCKING SCREW 85MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982049797), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A ONE (1) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE AND ONE (1) 5.0 MM CANNULATED LOCKING SCREW 85 MM WERE BROKEN AND NONUNION OF THE LEFT FEMUR. THE PLATE BROKE AT THE JUNCTION OF THE SECOND COMBI HOLE. AN 85 MM 5.0 CANNULATED LOCKING SCREW AS BROKE AT THE SCREW HEAD. THE OTHER CANNULATED LOCKING SCREWS AND CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. IT WAS REVISED WITH ANOTHER PLATE. INITIAL DATE OF THE SURGERY WAS ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: 5.0 MM CANNULATED LOCKING SCREWS 85 MM (PART # 02.205.085, LOT # UNKNOWN, QUANTITY 2) 5.0 MM CANNULATED LOCKING SCREWS 80 MM (PART # 02.205.080, LOT # UNKNOWN, QUANTITY 2), 5.0 MM CANNULATED LOCKING SCREW 35 MM (PART # 02.205.035, LOT # UNKNOWN, QUANTITY 1), 4.5 MM CORTEX SCREW SELF-TAPPING 36 MM (PART # 214.836, LOT # UNKNOWN, QUANTITY 3), 4.5 MM CORTEX SCREW SELF-TAPPING 44 MM (PART # 214.844, LOT # UNKNOWN, QUANTITY 2), 4.5 MM CORTEX SCREW SELF-TAPPING 46 MM (PART # 214.846, LOT # UNKNOWN, QUANTITY 1), 4.5 MM CORTEX SC
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 8670768 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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